The Associate Director, Clinical Bioanalysis, will be responsible and accountable for executing clinical bioanalytical strategies and activities for assigned programs and studies from early through late-stage clinical development and approval, including post marketing activities, managing outsourcing efforts, and collaborating with cross-functional stakeholders including clinical pharmacology, DMPK, translational medicine, clinical development, clinical operation, biometrics, regulatory, clinical QA, finance, and legal. This position will report to the Director, Clinical Bioanalysis, and work on-site at our Waltham, MA office.
What You’ll Do:
- Develop and implement bioanalytical strategy for compounds from first-in-human to later phases of clinical development (phase 2 and 3 studies and NDA/MAA submissions) to ensure timely, quality, and compliant delivery of clinical bioanalytical support.
- Represent the department as bioanalytical subject matter expert on cross-functional study teams and manage and resolve problems or issues relevant to clinical bioanalysis.
- Provide scientific and technical oversight to the bioanalytical vendors on method development/validation/transfer, and sample analysis.
- Review bioanalytical contracts, review bioanalytical study plans and data, provide data transfer agreements, review and approve method validation and bioanalytical reports and ensure their regulatory compliance.
- Identify, evaluate, and select vendors to support quantitative bioanalysis of clinical study samples in a regulated (GLP, GCLP) environment.
- Participate in regular vendor meetings, build and maintain positive relationships with external vendors.
- Ensure delivery of clinical bioanalysis data and reports with high quality according to timelines.
- Collaborate with colleagues within the department, internal stake holders (i.e., data management, clinical operations, CMC, clinical QA, procurement, legal, regulatory, etc.).
- Contribute to the preparation and review of relevant sections of clinical and regulatory documents and response to queries from regulatory agency on clinical bioanalysis.
- Contribute to optimizing and improving the operational performance, quality, and productivity of the function.
Qualifications
What You’ll Bring:
- An advanced degree (PhD) in analytical chemistry, organic chemistry, biochemistry, molecular/cell biology, or a closely related scientific discipline.
- 5+ years of relevant pharmaceutical industry experience.
- Direct hands-on bench-level experience developing and implementing bioanalytical assays in nucleic acid (antisense oligonucleotide, siRNA, mRNA, gene therapy), and biologics clinical development and approval process with the capability to advise on assay design, method development and validation, and address any issues that arise during assay development and sample analysis is required.
- Experience and familiarity with current bioanalytical regulatory guidelines are required.
- Strong scientific and technical skills in Ligand Binding Assays and Immunogenicity such as ELISA, MSD ECL, cell-based methods, PCR, etc. are required.
- Experience in managing external vendors is highly preferred.
- Experience with writing and reviewing clinical bioanalytical reports and/or contributing to regulatory submissions.
- Organized and detail-oriented with the ability to multi-task and handle multiple projects.
- Excellent written and verbal communication skills and strong negotiation skills.
- Demonstrated ability to work effectively and collaboratively on cross-functional teams.
- Previous experience in small molecule bioanalysis (LC-MS) is a plus.
Additional Information
Benefits:
- Competitive salary and annual bonus.
- Comprehensive benefits package including medical, dental, vision insurance, 401(k) retirement plan with company match, and more.
- Generous parental leave and family planning benefits.
- Outstanding culture and opportunities for personal and professional growth.
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EQUAL EMPLOYMENT OPPORTUNITY INFORMATION
Deciphera is committed to equal employment opportunity and values diversity. To ensure that we comply with reporting requirements, we invite you complete the confidential survey at the end of this application. Providing this information is optional. It will not be accessible or used in the hiring process, and has no effect on your opportunity for employment. This information will also be treated confidentially. We are committed to make all hiring decisions and other employment decisions on a non-discriminatory basis.